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Procedure Name

Granting permission for organizations/individuals to export/import finished drugs/medicines that contain an amount of addictive substances and for organizations to export/import drugs under non-commercial regime

Description

Category	License/Permit
Responsible Agency	Drug Administration of Vietnam - Ministry of Health Address: 138A Giang Vo - Ba Dinh - Hanoi Phone: (+844) 3736 (ext: Email: cqldvn@moh.gov.vn
Legal base of the Procedure	Circular 39/2013/TT-BYT prescribing the management of curative drugs/medicines for human use imported/exported under non-commercial regime Circular 05/2016/TT-BYT regulating medications prescribed for outpatients
Processing time	Within 07 working days from the date of reception of adequate and valid dossier
Fee	VND 0

Required Documents

No.	Type of documents	Note
1	An application form (Form 1a/PMD or Form 1b/PMD)	01 original copy
2	A copy of the identity card or passport of the person importing or exporting the drugs/medicines under non-commercial regime (to produce the original of the identity card or passport when carrying out customs procedures)	01 photocopy
3	Attached documents: A prescription or medical examination book or medical records or related documents	01 original copy
4	A prescription made up by a Vietnamese doctor or an outpatient medical examination book made according to the form specified in Appendix I of Circular No. Circular No. 05/2016/TT-BYT regulating medications prescribed for outpatients. A prescription made up by a foreign doctor or an outpatient medical examination book made according to the contents specified in Clause 1 Article 5 off Circular No. 05/2016/TT-BYT regulating medications prescribed for outpatients.	01 original copy

Process Steps

Step 1	The applicant shall submit a dossier of Application to the Drug Administration of Vietnam - Ministry of Health
Step 2	The Drug Administration of Vietnam shall receive and examine the dossier.
Step 3	Reply the applicant with results within 7 days. In case of refusal, the Administration shall reply in writing and clearly state relevant reasons.

Process Map:

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This procedure apply to theses Measures.

name	description
Non-commercial imported or exported addictive medicines	1. Non-commercial imported or exported medicines shall be used only for treatment of diseases of individuals who request the non-commercial import or export of medicine and individuals working in organizations requesting the non-commercial import or export of medicines or their family members. Non-commercial imported medicines may neither be sold in the market nor used for any other illegal purposes. 2. Individuals and organizations requesting the non-commercial import or export of medicines shall take responsibility for the origin and quality of such medicines. 3. Non-commercial imported or exported medicines must have labels indicating their appellations, active ingredients, concentrations, contents and expiry date.

name

description

Non-commercial imported or exported addictive medicines

1. Non-commercial imported or exported medicines shall be used only for treatment of diseases of individuals who request the non-commercial import or export of medicine and individuals working in organizations requesting the non-commercial import or export of medicines or their family members. Non-commercial imported medicines may neither be sold in the market nor used for any other illegal purposes. 2. Individuals and organizations requesting the non-commercial import or export of medicines shall take responsibility for the origin and quality of such medicines. 3. Non-commercial imported or exported medicines must have labels indicating their appellations, active ingredients, concentrations, contents and expiry date.